Completed

Face Mask Therapy and Rapid Maxillary Expansion on Blood Oxygen Levels in Class III Malocclusion

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What is being tested

Class III Malocclusion

Other
Who is being recruted

Malocclusion+1

+ Malocclusion, Angle Class III

+ Stomatognathic Diseases

From 6 to 10 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorBiruni University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on the effects of using a face mask therapy combined with rapid maxillary expansion (RME) in children with a specific dental issue called Class III malocclusion. This condition occurs when the upper jaw is too far back or the lower jaw is too far forward, or both. The therapy aims to encourage the forward growth of the upper jaw, helping to realign the teeth and improve the bite. The study is important because it examines how this treatment might also impact blood oxygen levels and breathing, especially since mouth breathing is common in people with this condition and can affect overall respiratory health. Participants in the study will undergo treatment involving the use of a face mask appliance, which applies gentle pressure to move the upper jaw forward. This treatment is often paired with RME to enhance the outcome. The study will monitor changes in the dental alignment and airway spaces, as well as measure blood oxygen levels using a device called a pulse oximeter. This device uses light to determine how much oxygen is in the blood, providing insights into how the treatment affects breathing. The potential benefits of the study could include improved dental alignment, better breathing, and a better understanding of how these factors are connected.

Official TitleEvaluation of the Effect of Face Mask Therapy and RPE Application on Blood Oxygen Levels
NCT06939179
Principal SponsorBiruni University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 6 to 10 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MalocclusionMalocclusion, Angle Class IIIStomatognathic DiseasesTooth Diseases

Criteria

Inclusion Criteria: 6-10 years of age Class III Malocclusion \- Exclusion Criteria: * +10 years of age

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
group will be administered a rapid upper jaw expansion protocol with a face mask device and will be asked questions about the airway and its quality. The rapid maxillary expansion appliance applied to this group is bonded hyrax type.

Group II

Experimental
Thisgroup, a bonded appliance without an expansion effect on the upper jaw was designed and applied. A petit-type facemask appliance will be applied with the appliance and respiratory quality will be questioned.

Group III

Active Comparator
The control group was asked about their respiratory tract and quality on the day they were first admitted to our clinic, pulse oximetry measurements will be made and they were called back at the end of 6 months, which is the average face mask treatment period, and this process was repeated.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Biruni University

Istanbul, Turkey (Türkiye)Open Biruni University in Google Maps
CompletedOne Study Center
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